Scenario_1.JPG

Company 1 is under contract by company 3 to create the API. Company 3 would include company 1 as an establishment in addition to
company 2 in its drug listing and include the DUNS numbers of both companies. Company 1 does not list separately.

Open question: Can Co. 3 use the NDC number that Co. 1 used to drug list the product?

Scenario_2.JPG

MyPharma site 1 is the labeler and all of the establishments are contact manufacturers. Only MyPharma sends in the SPL with all
5 establishments in the listing file. All establishments register. The non-US sites provide a US agent and the site in Germany includes
MyPharma site23 as an importer.

Open Question: Is there an alternative process where Coaters lists Bulks R Us and MyPharma just lists Coaters?

Scenario_3.JPG


MyPharma is the labeler and the sites are contract manufactures. MyPharma sends in the SPL with all of the establishments
included. All sites register except MyPharma site 1 if their only function is distribution.

Open Question: Regardless of how many different plants there are for MyPharma, does each one need to be listed separately for each process of the manufacturing?